Z-1797-2014Class II

IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and...

Name: Z-1797-2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and...
Creator: Boston Scientific Corporation
Published: 2014-05-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-05-15 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction... on 2014-05-15. FDA classified it as Class II and gives the reason as "Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1797-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Posted: 2014-06-16
Terminated: 2015-06-25
Recalling firm: Boston Scientific Corporation
Product: IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Product code: OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Reason for recall: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Root cause tag: manufacturing process
FDA root cause: Use error
Action: Customers were informed of the recall via overnight letter sent on May 15, 2014.
Quantity in commerce: 968 units total all models
Distribution: Nationwide Distribution.
Product codes and lots: Catalog Number: PM4790; Material Number: M004PM47900; Serial numbers: 16538009, 16743272, 16743273, 16872937 Expiry Dates: May 11, 2014 to January 13, 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1797-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1794-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16
Z-1795-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16
Z-1796-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16
Z-1797-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16
Z-1798-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16
Z-1799-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16

Product code OAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)